• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceILIAC WALLSTENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, MN 55311-1566
PMA NumberP940019
Supplement NumberS008
Date Received07/12/2001
Decision Date08/13/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
-
-